Medichoice Fluoride Paste, Dentifrice
FDA Label NDC 39892-0602
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Fluoride (NDC 39892-0602). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, keep out of reach of children under 6 years of age., directions, inactive ingredients, pacakge labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Monoflurophosphate - 0.76% (0.15% w/v fluoride ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Keep Out Of Reach Of Children Under 6 Years Of Age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or a doctor.
Inactive Ingredients
CALCIUM CARBONATE,WATER,SORBITOL,PRECIPITATED SILICA,SODIUM LAURYL SULFATE, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE TETRA SODIUM PYROPHOSPHATE, SODIUM SACCHARIN,METHYLPARABEN,TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400,PROPYLPARABEN
Pacakge Labeling:
Label2 (Label2)
Label3 (Label3)
* Please review the disclaimer below.
